Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

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Brief Title

Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

Official Title

RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not known whether combining chemotherapy with bone marrow or
      peripheral stem cell transplantation is more effective than combination chemotherapy alone in
      treating men with germ cell tumors.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with or without bone marrow or peripheral stem cell transplantation in treating men with
      previously untreated germ cell tumors.
    

Detailed Description

      OBJECTIVES:

        -  Compare the efficacy of bleomycin, etoposide, and cisplatin (BEP) with or without
           high-dose carboplatin, etoposide, and cyclophosphamide plus autologous bone marrow or
           peripheral blood stem cell transplantation in male patients with poor- or
           intermediate-risk germ cell tumors.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare prospectively the prognosis in terms of the rate of decline of the serum tumor
           markers, human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP), in patients
           treated with these regimens.

        -  Correlate hCG and AFP with complete response and survival in patients treated with these
           regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center and risk status (poor vs intermediate). Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive bleomycin IV on days 1, 8, and 15 and etoposide (VP-16) IV over
           30-60 minutes and cisplatin (CDDP) IV over 30-60 minutes on days 1-5 (BEP). Filgrastim
           (G-CSF) is administered subcutaneously (SC) on days 7-16 or until blood counts recover.
           Treatment continues every 3 weeks for 4 courses in the absence of disease progression or
           unacceptable toxicity. G-CSF is discontinued 24 hours before initiating subsequent
           courses of chemotherapy, and withheld on days of bleomycin administration.

        -  Arm II: Patients receive 2 courses of BEP and G-CSF as in arm I. Patients who have no
           marrow involvement with tumor undergo harvest of autologous bone marrow before the first
           or second course of BEP. Patients who have bone marrow involvement with tumor undergo
           harvest of G-CSF-mobilized autologous peripheral blood stem cells (PBSC) on days 17-21
           of the first and/or second courses of BEP. When blood counts recover, patients receive
           high-dose intensification comprising carboplatin IV over 1 hour, VP-16 IV over 30-60
           minutes, and cyclophosphamide IV over 1 hour on days -5 to -3. Autologous bone marrow or
           PBSC are reinfused over 15-20 minutes on day 0. G-CSF is administered SC beginning 24
           hours after transplantation and continuing until blood counts recover. Beginning 1-3
           weeks after hospital discharge for the first transplantation and after recovery from any
           toxic effects, patients with a Karnofsky performance status of 70-100% receive a second
           course of high-dose intensification plus a second bone marrow or PBSC transplantation in
           the absence of disease progression or unacceptable toxicity.

      Patients on both arms with brain metastases at presentation undergo radiotherapy and/or
      surgery concurrently with BEP, if medically indicated.

      Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor
      marker levels after completion of treatment on arm I or II undergo surgical resection of all
      residual masses. Patients who have no residual malignant tumor or undergo complete resection
      of only a mature teratoma receive no further therapy. Patients on arm I who undergo complete
      resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without
      bleomycin. Patients on arm II who undergo complete resection of residual malignant tumor
      receive no additional chemotherapy. Patients with an unresectable residual malignant tumor
      receive additional therapy at the discretion of the treating physician. Patients with
      residual tumor marker (AFP and hCG) positivity after treatment on arm I or II undergo
      resection of residual masses if tumor marker values fall to normal by marker half-life.

      PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this
      study within 4.4 years.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Childhood Germ Cell Tumor

Intervention

bleomycin sulfate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

270

Start Date

September 1994

Completion Date

July 2006


Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically proven poor-risk, nonseminoma germ cell tumor

               -  Must meet 1 of the following 3 conditions:

                    -  Testis or retroperitoneal primary site without visceral metastasis but with
                       any of the following tumor marker values:

                         -  Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal
                            (ULN)

                         -  Human chorionic gonadotropin (hCG) greater than 50,000 IU/L

                         -  Alpha-fetoprotein (AFP) greater than 10,000 ng/mL

                    -  Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral
                       metastases (regardless of tumor marker values), including the following:

                         -  Bone

                         -  Brain

                         -  Liver

                         -  Other nonpulmonary viscera (e.g., skin, spleen)

                    -  Mediastinal primary site, regardless of presence/absence of visceral
                       metastasis or tumor marker values OR

          -  Histologically proven intermediate-risk, nonseminoma germ cell tumor

               -  Testis or retroperitoneal primary site with no visceral metastasis (except lung),
                  and with any of the following tumor marker values:

                    -  LDH 3-10 times ULN

                    -  hCG 5,000-50,000 IU/L

                    -  AFP 1,000-10,000 ng/mL OR

          -  Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more
             nonpulmonary visceral metastases (regardless of tumor marker values or primary site),
             including the following:

               -  Bone

               -  Brain

               -  Liver

               -  Other nonpulmonary visceral metastasis (e.g., skin, spleen)

          -  Histologic confirmation may be delayed, at the discretion of the protocol chairman,
             until after initiation of study therapy for patients with a testicular mass and
             elevated AFP or hCG if medical circumstances warrant immediate treatment

          -  Measurable or evaluable disease

          -  Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies
             required

        PATIENT CHARACTERISTICS:

        Age:

          -  12 and over

        Sex:

          -  Male

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  See Disease Characteristics

        Renal:

          -  Creatinine no greater than ULN* OR

          -  Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral
             obstruction by tumor allowed at the discretion of the protocol chairman

        Other:

          -  HIV negative

          -  No other concurrent malignancy except nonmelanomatous skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  At least 30 days since prior radiotherapy except for brain metastases or documented
             disease progression

          -  Recovered from the toxic effects of any prior radiotherapy

        Surgery:

          -  Recovered from the effects of any recent surgery
      

Gender

Male

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert J. Motzer, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00002596

Organization ID

SWOG-9442

Secondary IDs

MSKCC-94076


Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Robert J. Motzer, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

October 2003